Convergence technology in cancer medicine

Abstract

The field of convergence technology may be defined as an area of technologic innovation in which multiple devices or functionalities are combined within a single platform in a way that adds functional, operational or economic synergies. Within the field of medical devices, this concept embodies many different types of novel combinations representing syntheses of therapeutic, diagnostic and digital information technologies. In the current era of healthcare reform, such combinatorial technologies will be pressed to demonstrate improvements in comparative effectiveness compared with the use of separate independent components. Moreover, the new more stringent regulatory environment will require much greater levels of pre- and post-market safety reviews conducted under the auspices and authority of the US FDA Office of Combination Products. This branch of the FDA scrutinizes submissions and divides them into drugs, devices and biological products and includes many submissions previously regulated by disparate centers, such as the Center for Devices and Radiologic Health and the Center for Drug Evaluation and Research. The field of convergence technologies already amounts to a worldwide market extending to tens of billions of dollars and this article will attempt to summarize some of the key elements of this continued push for added value and more personalized medicine.

Keywords::

• convergence
• combination technologies
• device regulatory environment
• digital radiology
• dual-purpose devices
• image-guided radiotherapy

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.